RATIONALE: Radioactive iodine may be effective in reducing the rate of recurrence of liver cancer after surgery to remove the tumor. It is not yet known if radioactive iodine is more effective than no further treatment after surgery.

PURPOSE: Randomized phase III trial to determine the effectiveness of radioactive iodine in treating patients who have undergone surgery for liver cancer.

Arm II: After prior resection, patients undergo observation. Patients are followed monthly for 1 year and then every 3 months thereafter.

PROJECTED ACCRUAL: A minimum of 300 patients (150 per treatment arm) will be accrued for this study.

Eligibility

Ages Eligible for Study:

17 Years and older (Child, Adult, Senior)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

No

Criteria

DISEASE CHARACTERISTICS:

Histologically confirmed primary hepatocellular carcinoma (HCC)

Completely resected disease with clear margins

No residual disease by postoperative CT scan

No metastatic disease

PATIENT CHARACTERISTICS:

Age:

17 and over

Performance status:

Karnofsky 60-100%

Life expectancy:

Not specified

Hematopoietic:

WBC greater than 1,500/mm^3

Platelet count greater than 50,000/mm^3

Hepatic:

Bilirubin less than 2.92 mg/dL

PT less than 4 seconds over control

Renal:

Creatinine less than 2.26 mg/dL

Other:

No contraindication to contrast or radioactive iodine

No uncontrolled thyrotoxicosis

No other prior or concurrent malignancy

Not pregnant or nursing

PRIOR CONCURRENT THERAPY:

Biologic therapy

Not specified

Chemotherapy

Not specified

Endocrine therapy

Not specified

Radiotherapy

Not specified

Surgery

See Disease Characteristics

Recovered from prior surgery

Other

No other prior treatment for HCC

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00027768